What is CMDh?

April 26, 2019 Off By idswater

What is CMDh?

Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) was set up in 2005. It replaced the informal Mutual Recognition Facilitation Group.

What is Mutual recognition Procedures?

A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.

What is Repeat Use procedure?

What Is A Repeat Use Procedure? According to the CMDh the ‘Repeat Use Procedure'(RUP) is the use of the Mutual Recognition Procedure (MRP) after the completion of a first MRP or Decentralised Procedure (DCP) for the recognition of a marketing authorisation by other Member States (MS).

What is CMDh ema?

Coordination Group for Mutual Recognition and Decentralised Procedures – Human: the group responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure.

What is RMS and CMS?

The Member State that has already authorised the product is known as the Reference Member State ( RMS ). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member States ( CMS ).

What Decentralised procedure?

The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State.

What is an MRP procedure?

The mutual recognition procedure ( MRP ) is a European authorisation route resulting in a mutually recognised product. The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member States ( CMS ). The CMS is asked to mutually recognise the MA of the RMS .

Who is HMA?

The Heads of Medicines Agencies ( HMA ) is a network of the heads of the National Competent Authorities ( NCA ) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area.

What is a national procedure?

National Procedure (NP) It is useful for manufacturers who aim to obtain market authorization in specific EU member states. In this procedure, applications are reviewed by the competent authorities of the respective EU member state. Each EU member state has a national procedure of its own.

What is EU MRP procedure?

The mutual recognition procedure ( MRP ) is a European authorisation route resulting in a mutually recognised product. The Member State that has already authorised the product is known as the Reference Member State ( RMS ).

What is HMA in law?

CLOSE. Section 13 & 13A Hindu Marriage Act 1955 (HMA) Divorce.

How does HMA VPN Work?

HMA hides the user’s IP address and other identifying information by routing the user’s internet traffic through a remote server. However, experts note that the company does log some connection data including the originating IP address, the duration of each VPN session, and the amount of bandwidth used.